Portable rechargeable led red light cavity healing devices

ABSTRACT

A light-emitting diode (LED) therapy device and method of use is provided that increases healing of tissues by targeting damaged tissue at a predetermined wavelength and pulsed at a predetermined frequency. The device includes a housing and a light radiation module enclosed within the housing. The light radiation module includes an LED, a controller unit connected to the LED to control wavelength and pulsed frequency of the LED, and a rechargeable power source. The device also includes a light-diffusing member connected to the housing designed to diffuse light emitted from the LED to damaged tissue in a human cavity. Light in the red or near infrared range and pulsed at a Nogier frequency increases the effectiveness of the LED device to stimulate healing of damaged tissues. Particular devices include incorporation into a pacifier for healing an infant&#39;s gums, or nasal, auditory, vaginal, or anal cavities and adults or children.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and benefit of U.S. ProvisionalPatent Application Number 62/339,032, filed May 19, 2016, the content ofwhich is incorporated by reference in its entirety.

FIELD OF THE DISCLOSURE

The present invention relates to a healing device and method, and moreparticularly, to the use of red light to aid in wound healing.

BACKGROUND OF THE INVENTION

The use of light for healing has long been practiced. Specific lightwavelengths have been used to treat various ailments and to stimulatethe body's natural tissue healing abilities. Light emitting diodes(LEDs) that emit light in the red wavelength (around 630 nm-700 nm) havebeen shown to decrease pain, aid in wound healing, and increase skinrejuvenation.

The mechanism of how red light therapy aids in tissue healing is notcompletely understood, but red light has been shown to increase releaseof ATP, an important source of energy, which thereby aids in activityperformance. (See “Light-emitting diode therapy in exercise-trained miceincreases muscle performance, Cytochrome C oxidase activity, ATP andcell proliferation,” Ferraesi et al., J Biophotonics. 2016 September;9(9):976). Light, especially light in the red and near-infrared rangehas been shown to have the ability to penetrate skin layers and energizefibroblast cells to produce collagen and elastin, which helps repairskin damage. LED light therapy has also been shown to increase growth ofepithelial cells, improve recovery of musculoskeletal training injuries,and reduce pain in children suffering from oral mucositis. (See “Effectof NASA Light-Emitting Diode Irradiation on Wound Healing,” Whelan H T,J Clin Laser Med Surg. 2001 December; 19(6):305-314). Animal studieshave shown that LED light therapy increases cell growth in mouse-derivedfibroblasts, rat-derived osteoblasts, rat-derived skeletal muscle cellsand also has the ability to decrease wound size. Id.

Most devices that use LEDs for healing, such as the device disclosedEuropean Pat. App. Pub. No. EP2044973A1 to Vibor, are based on using amatrix of LEDs on a matrix board. These types of devices are similar totanning beds, except instead of UV lamps within the bed, the lamps arereplaced with red LEDs. Although the large bed devices are useful fortreating certain types of tissue damage, they are bulky and expensive.They also require the user to dedicate several hours per week in orderto receive a sufficient amount of light to observe positive effects.

In additional to LED beds, other types of devices have been used to aidin body repair. Light therapy bandages have been used to treat wounds,such as the one disclosed in U.S. Patent Pub. No. 20070233208A1 to Kurtzet al. Bandage devices such as these are most effective for topicalwounds. Other devices, such U.S. Patent Pub. No. 20090088824A1 to Bairdet al. uses a handheld wand-like device for LED based phototherapy torejuvenate cells.

In addition to devices that stream a constant light source to a woundedarea, therapy devices also exist that pulse light to treat wounds, suchas the wand device disclosed in U.S. Patent Pub. No. 20050015121A1 toMolina, which uses pulsed light having a wavelength between 600 nm toabout 980 nm, well into the infra-red range. While these devices may beeffective to treat certain types of wounds in specific areas of thebody, there remains a need for light therapy devices that are easy touse, inexpensive to manufacture and can effectively treat wounds thathave traditionally been difficult to expose to light.

BRIEF SUMMARY OF THE PRESENT INVENTION

The present invention provides for devices that are portable,rechargeable, and use light emitted from diodes in the range of 600-700nm in order to speed the wound healing process and decrease painassociated with wounds. The devices are especially useful for treatingwounds in the oral, aural, nasal, vaginal, and anal cavities of aperson. These wound areas have traditionally been difficult to treatusing light therapy because light from hand-held and light bed devicescannot penetrate body cavities well.

Advantages of the present invention over other types of wound therapy,including light therapy and traditional wound healing methods, are thatthe devices of the present invention are drug-free, wearable, cordless,made of germ resistant materials, and have the capability of connectingwirelessly with mobile devices, and can diffuse light to treat tissuewithin a large area of the cavity.

In one embodiment the LED therapy device includes a housing and lightradiation module substantially enclosed within the housing. The lightradiation module includes an LED for emitting light at a predeterminedwavelength, a power source electrically connected to the LED, and acontroller unit connecting the power source and LED. The controller unitis capable of controlling pulse frequency of the LED at a predeterminedfrequency. The device also includes a light-diffusing member connectingto the housing. The light-diffusing member is designed to diffuse andproject light emitted from LED to a wide area of tissue located withinthe cavity.

In one aspect of the invention, the LED wavelength of light is between600 and 700 nm, and the light is pulsed at a Nogier frequency (292 Hz),or a harmonic of the Nogier frequency (i.e. 584 Hz, 1168 Hz, 2238 Hz,etc.). Light pulsed at the Nogier frequency or harmonic of the Nogierfrequency increases the tissue repair rate compared to the tissue repairrate of tissue treated by light not pulsed at the Nogier frequency.

Embodiments of the invention can take many forms to fit within specificcavities. In one aspect, the embodiment is in the form of an infantpacifier. This form is advantageous for healing the gums or otherlegions within the mouth of an infant. This embodiment is especiallyuseful for when the infant is teething. In this embodiment, thelight-diffusing member is a flexible nipple made from silicone or otherflexible elastomeric material. When the infant places the pacifier inhis or her mouth, light from the LED diffuses through the nipple andilluminates the entire oral cavity, including the gums. This device ismore effective at treating gum wounds than a hand-held light therapydevice, or a light therapy bed, because a silicone nipple within themouth is better capable of diffusing light throughout the entirety ofthe oral cavity than a hand-held wand or light therapy bed.

The silicone nipple is designed in order to maximize the internalreflection of the light and to be an optical light guide that directsthe LED red light toward the front gums and the back gums of an infant.In one embodiment, there is a single LED covered by a light pipe thatdirects the light into a wide angle increase the light coverage of thefront and back gums of an infant. The light pipe also has the mechanicalfunction of holding the silicone nipple in place to prevent detachmentduring intense suction.

In another aspect of the invention, the device is configured forparticular use in the ear. The housing includes an optical guide fordirecting light through the housing. The optical guide is characterizedas having an elongated tubular region with a first end that is inproximity to the LED and a second end opposing the first end. Thelight-diffusing member is a removable flexible silicone cap designed toattach to the second end of the elongated tubular region and projectlight into and throughout the ear canal, which fitting firmly within oneend of the ear canal.

In yet another aspect of the invention, the device is configured to fitinto the nostrils of human. Each nostril is fitted with a separatenostril LED device connected together with a bridging member so thatthere are two devices connected to each other by the bridging member.The optical guide of the first device and the optical guide of thesecond device are spaced between 1 and 3 centimeters from each other anddesigned to fit within two nostrils of a human. Light emanating from thefirst and second devices is directed to a nasal cavity of a human.

In yet another aspect of the invention, the device is configured to fitwithin the vaginal cavity or anal cavity of a person to aid in repair ofvaginal or anal tissue. The device is characterized as having anelongated body for insertion into anal or vaginal cavity. The housingalong the elongated body is a transparent or translucent shell,preferably made silicone rubber or other elastomeric composition. Thehousing encloses an optical guide for placement of a plurality of LEDsalong the longitudinal axis of the device. The optical guide isconnected to a compartment enclosing a rechargeable power source.Optionally covering this embodiment is elastomeric tubular sheath, suchas a condom or other type of latex sheath, designed to fit over theelongated housing and generally conform to the shape of the elongatedhousing. The condom acts as a protective layer between the device anduser. The condom may be coated with a lubricant to aid in smoothinsertion into the cavity. The lubricant may comprise a lotion orointment that further aids in tissue repair such as ointments havingactive ingredients of petrolatum and key ingredients of mineral oils,ceresin, lanolin, glycerine, panthenol, vitamin B, and bisabolol. Thecombination of the translucent elongated housing, elastomeric sheet, andointment aid in light dispersion so that a greater amount of tissue canbe exposed to LED light when the device is inserted into the cavity.

In yet another embodiment of the invention, a method of promotinghealing of tissues using red LEDs. The method includes inserting adevice into an animal cavity, such as the mouth, ear canal, nostril,anal or vaginal cavity. The device includes a housing, a light radiationmodule substantially enclosed within the housing, an LED having at leastone predetermined wavelength, a controller unit connected to the LED,the controller unit capable of controlling pulse frequency of the LED atleast one predetermined frequency, a power source, and a light diffusingmember connected to the housing. The method includes the step ofilluminating the LED, preferably at a wavelength between 600 nm and 700nm, and pulsing the LED at a Nogier frequency, such as at a frequency of292 Hz, 584 Hz, or 1168 Hz.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross sectional view of a pacifier embodiment of the devicedesigned for use in the oral cavity of an infant;

FIG. 2 is a side view of the embodiment of FIG. 1;

FIG. 3 is a perspective view of the pacifier embodiment of FIGS. 1 and2;

FIG. 4 is an exploded view of another pacifier embodiment, theembodiment having a light pipe to guide and disperse light from the LEDto the front and back gums of the mouth of an infant;

FIG. 5 is a cross sectional view of an embodiment of the device designedfor use in the ear or nose of a person;

FIG. 6 is a top perspective view of the embodiment of FIG. 5;

FIG. 7 is a cross sectional view of an embodiment of the device designedfor use within the vaginal or anal cavity of a person;

FIG. 8 is a perspective view of the embodiment of FIG. 7.

DETAILED DESCRIPTION OF EMBODIMENTS

The invention now will be described more fully hereinafter withreference to the accompanying drawings, in which embodiments of theinvention are shown. This invention may however be embodied in manydifferent forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art.

It will be understood that when an element is referred to as being “on”another element, it can be directly on the other element or interveningelements may be present therebetween. As used herein, the term “and/or”includes any and all combinations of one or more of the associatedlisted items.

It will be understood that, although the terms first, second, third etc.may be used herein to describe various elements, components, regions,layers, and/or sections, these elements, components, regions, layers,and/or sections should not be limited by these terms. These terms areonly used to distinguish one element, component, region, layer, and/orsection from another element, component, region, layer, and/or section.

It will be understood that the elements, components, regions, layers andsections depicted in the figures are not necessarily drawn to scale.

The terminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting of the invention.As used herein, the singular forms “a,” “an,” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” or “includes” and/or “including” when used in thisspecification, specify the presence of stated features, regions,integers, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features,regions, integers, steps, operations, elements, components, and/orgroups thereof.

Furthermore, relative terms, such as “lower” or “bottom,” “upper” or“top,” “left” or “right,” “above” or “below,” “front” or “rear,” may beused herein to describe one element's relationship to another element asillustrated in the Figures. It will be understood that relative termsare intended to encompass different orientations of the device inaddition to the orientation depicted in the Figures.

Unless otherwise defined, all terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs. It will be further understood that terms, such asthose defined in commonly used dictionaries, should be interpreted ashaving a meaning that is consistent with their meaning in the context ofthe relevant art and the present disclosure, and will not be interpretedin an idealized or overly formal sense unless expressly so definedherein.

Exemplary embodiments of the present invention are described herein withreference to idealized embodiments of the present invention. As such,variations from the shapes of the illustrations as a result, forexample, of manufacturing techniques and/or tolerances, are to beexpected. Thus, embodiments of the present invention should not beconstrued as limited to the particular shapes of regions illustratedherein but are to include deviations in shapes that result, for example,from manufacturing. The invention illustratively disclosed hereinsuitably may be practiced in the absence of any elements that are notspecifically disclosed herein.

Turning to the various embodiments, all embodiments can be used to aidin healing wounds, irritation or infections in human cavities. Theembodiments use an electrically rechargeable power source and at leastone LED light in the range of about 630 nm to 700 nm (red and nearinfrared), which has been shown to stimulate wound healing and decreasepain associated with wounds. Light outside this range, from 600 nm to980 nm has also been shown to have positive effects because body tissuecan absorb light having wavelengths in this range. In preferredembodiments, the LED light is in the range of 660 nm to 680 nm. Lighthaving wavelength in this range has the ability to penetrate layers ofskin (up to around 2 mm-7 mm) and energize fibroblast cells that producecollagen and elastin, thereby helping repair damaged tissue. Embodimentsallow users to wear the device during the day and night, profiting fromthe healing effects of red light without dedicating long hours underfixed lamps or inside LED light beds. As light therapy efficiencydepends on the exposure time, light therapy approaches using thesedevices will yield faster and better effects by being used for severalhours per day instead of several sessions of just a few hours per weekor per month.

Embodiments of the present invention are advantageous over other lighttherapies because the present embodiments are specifically designed totarget wounds inside of cavities (oral, aural, nasal, vaginal and anal)and also employ the use of predetermined wavelengths and LED pulsing tostimulate wound healing. While proponents of light therapy devices claimthat light therapy devices using lamps can reach internal areas of thehuman body by outside indirect exposure, these devices cannot be aseffective as directly applying light using device specifically designedto be inserted into a cavity having damaged tissue.

Embodiments are made of medical grade plastic and enclose a lightradiation module that controls an LED to emit wavelengths in the visiblered spectrum and near infrared. The light is optically directed insidehuman cavities via clear buffer, for example, a transparent ortranslucent silicone that is part of the device. To increase the healingeffects, emitted light is pulsed at “Nogier frequencies,” also known asthe cellular frequency. Nogier frequencies are frequencies in multiplesand factors of 292 Hz (e.g. 73 Hz, 146 Hz, 584 Hz, 1,168 Hz, 2,236 Hz,4,672 Hz, which are harmonics and factors of the Nogier frequencybecause these frequency can be attained by doubling 292 Hz or halving292 Hz one or more times). Light emitted at these frequencies aid inrepairing damaged tissue and increase healing process. Deviations ofthese frequencies from −30% to +30% have also been used to aid inhealing and may be employed to repair damaged tissue.

FIGS. 1-4 illustrate embodiments designed as a pacifier 10 for aninfant. Pacifiers utilizing lights are known, including US. Patent App.Pub. 20120209326A1 to Lutes et al., hereby incorporated for all purposesby reference in its entirety. In the present embodiment, FIGS. 1-4includes a housing 36, a light radiation module 16 that controls outputof one or more LEDs 2, and a light-diffusing member 18. In theembodiment shown FIGS. 1-4, the light-diffusing member 18 is a nippleand preferable is made from 100% food grade silicone and designed tomaximize the contact with an infant's gums, and maximize light diffusioninto the oral cavity. The pacifier 10 includes a handle 52 for theinfant to hold and a mouth shield 50 to prevent the infant frominserting the pacifier 10 entirely into the oral cavity. The nipple 18has a top region 28, middle region 32, and bottom region 30. The nipple18 includes an outer surface 24 and an inner surface 26 that encloses anipple cavity 34. The surfaces 24, 26 of the nipple 18 allow internalreflections of light emanating from an LED 2 to expose diffused radiatedlight throughout the entirety of the oral cavity. The light radiationmodule 16 comprises controller circuitry for at least one LED 2. LEDcontroller circuitry that can control intensity, pulse, and wavelengthof light have previously been disclosed, such as the controllercircuitry disclosed in U.S. Pat. No. 7,119,498 to Baldwin et al., fullyincorporated by reference in its entirety. LEDs may be those commonlyused in the art. In one embodiment the LEDs are type 5 mm 3.5V, and arecapable of emitting light between 660 nm and 680 nm. The LEDs 2 aredisposed on or near the surface of light radiation module 16 and may bea single LED or a plurality of LEDs within the housing 36. The lightradiation module 16 is preferable between 1 cm to 2 cm in width, but maybe of any width that can fit within a waterproof compartment 56surrounded by the housing 36 near the base 6 of the pacifier 10.

The light radiation module 16 and LEDs 2 connected to the module 16 arepowered by a power source 14 such as a battery. A preferable powersource is a rechargeable button cell lithium battery type cr2032. Thecontrol circuitry can pulse the LEDs 2 at or near the Nogier frequencyof 292 Hz. The LED can also pulse at harmonic frequencies at or nearNogier frequency, such as at 584 Hz and 1168 Hz. The light radiationmodule 16 can also be wirelessly controlled by though variety of means,including using Bluetooth technology using such as Bluetooth Modulea2dpC. The power source 14 can be charged by Qi wireless chargertechnology using an active coil (located inside a charging base) and apassive coil located in the electronic compartment of the pacifier.Various wireless charging technologies are well known and differenttypes wireless chargers may be used without department from the spiritinvention. The charging base can also have an ultraviolet lightintegrated in the top central part of base to sterilize the pacifierwhile it is charging. Bluetooth components may connect wirelessly to acontroller, such as an app on a smart phone to control the output of theLEDs. The variables that the controller may be able to affect includeintensity, pulse frequency, and wavelength.

Light emitted from the LED 2 can be controlled through a variety ofmeans. The LEDs 2 can be turned on or off via the use of a power buttonor press switch 60. The press switch 60 is connected to a conductivemember 98 (see FIG. 4) that is in electrical contact with the powersource 14 and circuitry on the light radiation module 16 so that bypressing the power button 60, the LED can selectively be turned on oroff. Preferably, the press switch 60 should require an amount of forcethat an adult can impart, but not an infant, so that an infant could notaccidentally actuate the switch. An adult force press switch 60 preventsunnecessary battery drain by reducing the chances that an infant couldturn the LEDs on when not in use. To prevent accidental turning on oroff of the LED 2 by an infant, the device may employ multiple pressswitches that must be depressed simultaneously in order to turn on oroff the device. An infant is unlikely to accidentally depress multiplepress switches simultaneously on the pacifier so this ensures that onlyan adult would likely turn the device on or off.

A safety feature that prevents the user from accidentally directinglight into the eyes is a light sensor 58 that activates the LEDs 2 onlywhen the sensor 58 is exposed to sufficient light emitted from the LEDs2. When the LEDs 2 are on and the pacifier 10 placed inside the infant'smouth, the sensor 58 would measure a high amount of light due to thereflection of the red light inside the infant's mouth back to the sensor58. However, if the pacifier 10 is outside of the infant's mouth, thesensor 58 would measure a drop of light intensity, and turn the LEDs 2off automatically. This sensor feature serves a double function, as itwill prevent the infant from receiving directly light into the eyesshould the pacifier 10 be removed or fall out of the infant's mouth, andit also saves batteries. Other types of sensors that detect theplacement of an object in a mouth can also be used and incorporated intothe present device, such as those disclosed in U.S. Patent App. Pub.20090198275A1 to Godown et al.

An alternative pacifier embodiment is shown in FIG. 4 in an explodedview. A single LED 2 is positioned within the nipple 18 and furthercomprises a light pipe 96 that is positioned on top of, and surrounds,the LED 2. Although a single LED 2 is shown, multiple LEDs could beplaced within the light pipe 96. The light pipe 96 serves a dualfunction. First, it spreads the emitted light to a wider angle, whichbetter expose the gums of an infant to light. Second, it mechanicallyholds the silicone nipple 18 to the other components of the pacifier 10thereby preventing detachment of the nipple during intense suction. AsFIG. 4 illustrates, the top of light pipe 96 fits through an aperture100 of the mouth shield 50. The base 104 of the light pipe 96 fits overthe LED 2 and is below the mouth shield 50. Since the base 104 of thelight pipe 96 is wider than the aperture 100 in the mouth shield, thelight pipe 96 remains securely in place. The top 102 of the light pipe96 is sized and shaped to securely fit within the interior cavity of thenipple and the light pipe 96 is press fit to attach to the nipple 18.

To account for the change of pressure inside the nipple 18 that occurswhen an infant bites or sucks the nipple 18, the light pipe 96 caninclude an aperture 94 to balance the air pressure inside the nipple 18with the air pressure of the compartment 56 housing the electricalcomponents. Having an aperture that connects the nipple cavity with thehousing 56, balances the air pressure within the device 10.

The light pipe 96 can have various features that increase theeffectiveness of distributing light within the nipple 18 to target aninfant's gums. The light pipe 96 can have guide walls that extend from aperimeter of the LED 2 to directly light upwards. When the light passesthe guide walls, the dome shaped top 102 of the light pipe 96 can anglethe light in various directions to ensure that light is beingdistributed at a wide angle within the nipple so that the light not onlyis directed to the tip of the nipple, but along the sides of the nippleas well.

The dimensions of the pacifier 10 shown in FIGS. 1-4 can be of a varietyof shapes and sizes. One embodiment about 1.75 inches (4.5 cm) inlength, about 2 inches (5 cm) in height and about 2 inches (5 cm) indepth.

Methods to effectively heal tissue involve exposure of damaged tissue tored light having at least a minimum threshold intensity for at least aminimum threshold time. Factors that influence the gum healing effectsby the light include distance that the gums are away from the lightsource and the exponential decay of light as it penetrates the gumtissue. In one embodiment, the light irradiance is approximately 70mW/cm². As the distance from the light source to the gums increase, theirradiance decreases significantly. For example, when the gums of theinfant are approximately two centimeters (one inch) from the nipple ofthe pacifier, the light irradiance of a light source of 660 nm in mucoustissues decreases to approximately 10 mW/cm². (See Bashkatov et al.,“Optical Properties of Skin, Subcutaneous, and Muscle Tissues: A Review,J. Innovative Opt. Health Sci., Vol. 4, No. 1 (2001) 9-38; and S. L.Jacques, Corrigendum: Optical properties of biological tissues: areview, Phys. Med. Biol. (2013) 58 R37. This irradiance is similar tothe irradiance of a low level of sunlight. Since sunlight does nottypically reach the gums of an infant the irradiance provided bypacifier is sufficient to reduce swelling and inflammation.

To achieve a median light irradiance of about 30 mW/cm² at about 1 mminside the mucous gum tissue, a dosage of approximately 8J/cm² providesenough light to develop new capillaries and allow a faster draining oflymphatic processes to increase gum healing. After inflammationdecreases, it is typical the inflammation recurs after approximately 30minutes. Therefore, in a preferred embodiment, light dosage can bedelivered in the following manner. The light of the pacifier is turnedon for approximately 2 minutes and 13 seconds at a value of 30 mW/cm²,which equates to 4J/cm². The pacifier is turned off for about 30 minutesand the pacifier is turned off (or removed from the infant's mouth) forapproximately 30 minutes and the light is then turned on for another 2minutes and 13 seconds to lead to a single dosage of 8J/cm² pertreatment. After one hour, the pacifier will turn off and shouldmanually be turned on again to restart a sequence of dosage delivery. Ina preferred embodiment, the pacifier should be used two to three timesper day for the one-hour sequence.

In another embodiment, the can be activated between between one minuteand three minutes, which provides either a higher dosage or lower dosagecompared to the embodiment where the light is on for two minutes and 13seconds. A decreased dosage based on a decreased amount of time ofexposure may not sufficiently activate gum healing, and a higher dosageon time, not only could have a diminishing returns effect, but maydecrease healing time to baseline healing time, comparable to no lighttherapy. In still further embodiments, the treatment sessions can be in15 minute, 30 minute, 45 minute or 60 minute intervals withoutdetracting from the spirit of the invention.

In another embodiment of the invention, the pacifier uses a smart lightdosage delivery. Instead of the light source being controlled by atimer, the light source is activated and deactivated being based on thetemperature of the infant's gums. Inflammation of gums is associatedwith a temperature increase of the gums. The pacifier includes athermocouple or temperature sensor 59 (as shown in FIG. 1) that iscapable of measuring the temperature of the top and bottom gums.Pacifier thermometers are known in the art, such as those disclosed inU.S. Pat. No. 5,178,466 to Chiu, U.S. Pat. No. 5,211,479 to Coffey, andU.S. Pat. No. 5,534,013 to Zeindler, each incorporated by reference intheir entireties. The pacifier monitors the gum temperature and deliversthe appropriate dosage of light to reduce inflammation. As thetemperature of the gums decreases due to reduction of inflammation,light source will deactivate. The circuitry 16 connected to thetemperature sensor 59 monitors and temperature and controls activationand deactivation of the light source. FIG. 1 illustrates two temperaturesensors 59, one disposed on the top side of the nipple and one disposedon the bottom side of the nipple, to each separately measure thetemperature of the top and bottom gums, respectively.

FIGS. 5 and 6 illustrate an embodiment of an LED device designed to fitwithin the ear canal or nostrils of a person. The nostril LED device 70comprises the same internal electrical components of the pacifier 10shown in FIG. 1, including a light radiation module 16, LED 2, powersource 14, and controller unit 16. The nostril LED device 70 iscomprised of two individual devices 80 a, 80 b that can individually beused as ear LED devices. The individual ear devices 80 a, 80 b areconnected by a bridge member 44. When the ear LED devices 80 a, 8 b areseparated from the bridge member 44, the ear LED devices 80 a, 80 b areadapted to fit within the ear of a person. Modifications can be made tothe nostril LED device 70 such that the bridge member 44 can permanentlyfix the ear devices 80 a, 80 b together.

The top of each ear LED device 80 a, 80 b has a flexible silicone cap 42(or can also be made from other elastomeric compositions). The devices80 a, 80 b can made in a variety of seizes to fit within the ear canalor nostril. The silicone cap 42 forms a flexible seal to hold thedevices 80 a, 80 b within the ear, similar to how the silicone caps ofear bud headphones form a flexible seal to prevent ear bud headphonesfrom falling out of the user's ears. The silicone cap 42 is preferablymade from a breathable material and acoustically permeable material orhave features, such as pores 82, that allow sound to travel through theear LED devices 80 a, 80 b. The silicone cap 42 may also have a hollowcenter to allow light to project through the cap 42 onto the user'snasal tissue or ear canal tissue. The cap 42 preferably is transparentor highly translucent material and preferably is made of 100% food gradesilicone.

The bridge member 44 preferably is elongated plastic material. Thelight-radiation modules are housed within the base 6 of waterproofcompartments 56 at each base 6. Since ear and nasal cavities of a personare smaller than the oral cavity, the nasal LED device 70 may containfewer LEDs than the embodiment designed as a pacifier 10 for oral useshown in FIGS. 1-4. In the nasal LED device 70 and ear LED device 80 a,80 b, only one or two LEDs may fit within the compartment 56. When thedevice 70 is on, light emanating from the LED projects from the LEDthrough the optical guide 38 enclosed by the elongated tubular region 40of the device 80 a, 80 b. Light projects out of the device and ontodamaged tissue. The elongated tubular region 40 is preferablycylindrical in shape but can be shaped in any manner to direct lightemitted from the light radiation module through the silicone cap 42.

When the light contacts wounds in the nasal cavity or ear canal, thewavelength and pulsed frequency of the light increases healing of thewounds as previously described. Preferably, light for nasal cavitieshealing is around 680 nm, and preferably between approximately 650 nmand 700 nm. Increased healing also occurs when the light is pulsed atthe Nogier frequencies. Light therapy using the nasal LED device 70reduces pain and increases speed of healing of irritated or infectednasal cavities of a person suffering from a cold, sinusitis, or othernasal ailment. Preferably, the light penetration depth is at leastbetween 2 mm-7.5 mm for nasal LED devices 70, which reduces pain andincreases the speed of healing of irritated or infected nasal tissue.For embodiments designed to fit the ear canal, use of the devices 80 a,80 b reduces pain and increases the speed of healing of ear infectionsfor infants and adults. Ear LED devices 80 a, 80 b preferably use awavelength of light between 640 nm to 680 nm and have a light depthpenetration of about 1 mm to 7.5 mm.

The dimensions of each of the ear devices 80 a, 80 b are approximately 1inch (2.5 cm) in length, 0.75 inches (2.0 cm) in height, and 0.75 inches(2.0 cm) in depth, but other sizes can be made to fit a variety ofcavities. In a preferred embodiment, the light power density(irradiance) is approximately 1.75 W/m².

FIGS. 7-8 illustrate an embodiment of an LED device 90 for use vaginalor anal applications using the same LED internal components described inthe previous embodiments. The vaginal LED device 90 has a top region 92,an elongated housing 88, and a base 86. The vaginal LED device 90 can besized to fit a variety of cavity sizes, but in a preferred embodiment isapproximately 2.5 inches long (about 6.4 cm) and 0.5 inches wide (about1.3 cm). Other embodiments between 1.0-6.0 inches long (2.5 cm to 15 cm)and 0.25-1.0 inches wide (0.6 cm to 2.5 cm) can be envisioned withoutdetracting from the purpose of the device 90. The light power density ofthe device in a preferred embodiment is approximately 7.5 W/m².

The elongated housing 88 has an outer transparent or translucent shell84 and an inner optical guide 38 within the shell 84. The outer shell 84is preferably made from a soft flexible silicone rubber case havingtopography to maximize diffusion of light and light scattering of LEDlight. Mechanisms of diffusing light include surface scattering fromroughness and subsurface scattering from irregularities in solids. Theoptical guide 38 is disposed substantially along the vertical axis ofthe vaginal device 90 following the direction of the elongated body 88.At least one, but preferably a plurality of LEDs are aligned along orwithin the optical guide 38 of the device 90 to increase irradiance. Theoptical guide 38 may be a hollow tubular structure within the device 90or other structure capable of guiding light along the vertical axis ofthe device 90. Providing power to the LEDs, as well as electroniccontrol, is a light radiation module 16 (illustrated in FIGS. 1 and 4).The light radiation module 16 and other components are housed within awaterproof compartment 56 at the base 86 of the vaginal LED device 90.When the device 90 is on, light emanates from the LEDs and is guidedthrough the optical guide 38 within the elongated body 88 and scattersin multiple directions out of the device 90 to maximize vaginal or analsurface exposure to the light.

For hygienic purposes, the vaginal LED device 90 may be covered with aone-time use flexible elastomeric sheath, such as a condom (not shown).To increase the effectiveness of the healing, the sheath may be coatedwith a lubricant ointment or active cream. Light therapy devices thatuse red LEDs, pulsed at known healing frequencies, in combination withapplying tissue healing lotions and ointments, increase theeffectiveness of the light therapy devices.

While the invention has been described in terms of exemplaryembodiments, it is to be understood that the words that have been usedare words of description and not of limitation. As is understood bypersons of ordinary skill in the art, a variety of modifications can bemade without departing from the scope of the invention defined by thefollowing claims, which should be given their fullest, fair scope.

What is claimed is:
 1. A light-emitting diode (LED) therapy device totarget surfaces within a cavity, the device comprising: (i) a housing;(ii) a light radiation module substantially enclosed within the housing,the light radiation module having, (a) an LED for emitting light havingat least one predetermined wavelength, (b) a controller unit connectedto the LED, the controller unit capable of controlling pulse frequencyof the LED for at least one predetermined frequency; (c) a power sourceelectrically connected to the controller unit; (iii) a light diffusingmember connected to the housing, the light diffusing member designed todiffuse and project light emitted from the LED.
 2. The device of claim1, and wherein the predetermined wavelength is between 600 nm and 700nm, and wherein the at least one predetermined frequency is at least oneof a Nogier frequency and a harmonic of the Nogier frequency, wherebylight pulsed at the Nogier frequency or the harmonic of the Nogierfrequency increases the rate of tissue repair compared to the rate oftissue repair when tissue is treated by light not pulsed at the Nogierfrequency.
 3. The device of claim 1, wherein the predeterminedwavelength is between 600 nm and 980 nm, and wherein the at least onepredetermined frequency is a predetermined frequency within 30 percentof a Nogier frequency.
 4. The device of claim 1, wherein the lightdiffusing member is a flexible silicone nipple having an outer surface,an internal cavity defined by an internal surface, a top region, amiddle region, and a base region substantially encircling the LED,wherein the top region of the silicone nipple permits light from the LEDto emit from the LED through the internal cavity of the nipple to thetop region of the silicone nipple to exit from the top region of thesilicone nipple, thereby allowing light form the LED to illuminate anoral cavity of a person when the silicone nipple is placed within theoral cavity; wherein the power source is a rechargeable battery.
 5. Thedevice of claim 1, wherein the light radiation module further comprisesa Bluetooth module and a wireless charging receiving inductive coil. 6.The device of claim 1, further comprising: a mouth shield between thelight radiation module and light diffusing member to prevents an infantfrom inserting the entirety the device into a mouth; a light pipepositioned on top of the LED and within an internal cavity of the lightdiffusing member, the light pipe having a base and a top, the top of thelight pipe angled to emit light at a wider angle compared to lightemitted by the LED without the light pipe, thereby increasing exposureof LED light to an infant's gums; wherein the light pipe comprises anaperture allowing for air to pass from the cavity of the nipple to awaterproof compartment enclosed by the housing, the aperture used forbalancing the air pressure between the internal cavity of the lightdiffusing member and the waterproof compartment; and, at least onetemperature sensor embedded within or adjacent to the light diffusingmember, the at least one temperature sensor adapted to measure atemperature of an infant's gums.
 7. The device of claim 2, wherein theNogier frequency is at least one of 292 Hz, 584 Hz, and 1168 Hz.
 8. Thedevice of claim 4, wherein the Nogier frequency is at least one of 292Hz, 584 Hz, and 1168 Hz.
 9. The device of claim 1, wherein the housingcomprises an optical guide for directing light through the housing, thehousing characterized as having an elongated tubular region, theelongated tubular region having a first end in proximity to the LED anda second end opposing the first end; wherein the light-diffusing memberis flexible silicone cap designed to attach to the second end of theelongated tubular region.
 10. The device of claim 9, wherein theremovable flexible silicone cap is made from a porous and acousticallypermeable material and designed to fit firmly within an ear canal of ahuman.
 11. A light-emitting diode (LED) therapy device comprising afirst device of claim 7 and a second device of claim 7, wherein thefirst and the second devices are connected to each other via a bridgemember; and, wherein the optical guide of the first device and theoptical guide of the second device are spaced between 1 and 3centimeters from each other and designed to fit within two nostrils of ahuman, whereby light emanating from the first and second devices isdirected to a nasal cavity of a human.
 12. The device of claim 1,characterized as having an elongated body, wherein the housing is anelongated housing comprised of a transparent or translucent siliconerubber; wherein the housing encloses an optical guide for placement of aplurality of the LEDs along a longitudinal axis of the device; whereinthe optical guide is connected to a compartment enclosing the powersource; and, wherein the power source is a rechargeable power source.13. The device of claim 12, further comprising an elastomeric tubularsheath designed to fit over the elongated housing and conform to thegeneral shape of the elongated housing.
 14. The device of claim 13,wherein the elastomeric tubular sheath is coated with a lubricant to aidin insertion of the device into a cavity.
 15. The device of claim 13,wherein the elongated tubular sheath is a latex sheath.
 16. The deviceof claim 13, wherein the housing is characterized has having a baseregion, the base region having an indentation to secure the tubularsheath to the elongated housing.
 17. A method of promoting healing oftissues using red LEDs, comprising: inserting a device into an animalcavity, wherein the device includes a housing, a light radiation modulesubstantially enclosed within the housing, an LED having at least onepredetermined wavelength, a controller unit connected to the LED, thecontroller unit capable of controlling pulse frequency of the LED atleast one predetermined frequency, a power source, and a light diffusingmember connected to the housing; illuminating the LED at a wavelengthbetween 600 nm and 700 nm; pulsing the LED at a Nogier frequency. 18.The method of claim 17 where in the Nogier frequency is at least one of292 Hz, 584 Hz, and 1168 Hz.
 19. The method of claim 17, whereininserting the device is characterized as inserting the device into atleast one of a mouth, an ear canal, a nostril, an anal cavity and avaginal cavity.